Delivering the National Diabetes Prevention Program: Assessment of Enrollment in In-Person and Virtual Organizations.

The aim of the US Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program (National DPP) is to make an evidence-based lifestyle change program widely available to the more than 88 million American adults at risk for developing type 2 diabetes. The National DPP allows for program delivery using four delivery modes: in person, online, distance learning, and combination. The objective of this study was to analyze cumulative enrollment in the National DPP by delivery mode. We included all participants who enrolled in CDC-recognized organizations delivering the lifestyle change program between January 1, 2012, and December 31, 2019, and whose data were submitted to CDC's Diabetes Prevention Recognition Program. During this time, the number of participants who enrolled was 455,954. Enrollment, by delivery mode, was 166,691 for in-person; 269,004 for online; 4,786 for distance-learning; and 15,473 for combination. In-person organizations enrolled the lowest proportion of men (19.4%) and the highest proportions of non-Hispanic Black/African American (16.1%) and older (65+ years) participants (28.2%). Online organizations enrolled the highest proportions of men (27.1%), younger (18-44 years) participants (41.5%), and non-Hispanic White participants (70.3%). Distance-learning organizations enrolled the lowest proportion of Hispanic/Latino participants (9.0%). Combination organizations enrolled the highest proportions of Hispanic/Latino participants (37.3%) and participants who had obesity (84.1%). Most in-person participants enrolled in organizations classified as community-centered entities (41.4%) or medical providers (31.2%). Online and distance-learning participants were primarily enrolled (93.3% and 70.2%, respectively) in organizations classified as for-profit businesses or insurers. Participants in combination programs were enrolled almost exclusively in organizations classified as medical providers (89%). The National DPP has reached nearly half a million participants since its inception in 2012, but continued expansion is critical to stem the tide of type 2 diabetes among the many Americans at high risk.

Cardiometabolic syndrome and associated factors among Ethiopian public servants, Addis Ababa, Ethiopia.

Non-communicable diseases (NCDs) are increasingly becoming the global cause of premature death encompassing cardiovascular diseases (CVDs), cancer, respiratory diseases and diabetes mellitus. However, cardiometabolic risk factors in the general population, especially among the high-risk groups have rarely been assessed in Ethiopia. The study aimed to assess the prevalence of metabolic syndrome, its components and associated factors among staff in the Ethiopian Public Health Institute (EPHI). An institutional-based cross-section study was conducted from March to June 2018 among EPHI staff members. A total of 450 study participants were involved in the study, and the World Health Organization NCD STEPS survey instrument version 3.1 was used for the assessment. The biochemical parameters were analyzed by using COBAS 6000 analyzer. Statistical package for the social science (SPSS) version 20 was used for data analysis. Both bivariate and multivariate logistic regression analyses were used to identify associated risk factors. p value < 0.05 was considered for statistical significance. The overall prevalence of metabolic syndrome was 27.6% and 16.7% according to IDF and NCEP criteria respectively, with males having greater prevalence than females (35.8% vs 19.4%). Central obesity, low high-density lipoprotein (HDL) and hypertension had a prevalence of 80.2%, 41.3%, and 23.6%, respectively. In multivariate analysis increasing age and having a higher body mass index (25-29.9) were significantly associated with metabolic syndromes. The magnitude of metabolic syndrome was relatively high among public employees. Preventive intervention measures should be designed on the modification of lifestyle, nutrition and physical activities, and early screening for early identification of cardiometabolic risks factors should be practised to reduce the risk of developing cardiovascular diseases.

Impact of comorbidities on mortality in hospitalized influenza patients with diabetes - Analysis of the Austrian Health Insurance.

AIMS: To assess the impact of characteristics and comorbidities on the hospitalization rate and 30- and 90-days all-cause mortality after hospitalization for influenza-related illness (IRI) in individuals with diabetes. METHODS: Data of 507,184 individuals with diabetes enrolled in the national Austrian Health Insurance database during 2013-2017 were analyzed. Hospitalization for IRI was defined as per International Classification of Disease 10 codes (J09, J10, J11). All-cause mortality was calculated for 30- and 90-days post-hospitalization. RESULTS: Of the total diabetes population, 1994 (0.4%) were hospitalized for IRI during 2013-2017. The rate of comorbidities was higher in individiuals who were hospitalized due to IRI as compared with the general diabetes population. Overall 30-days cumulative mortality following hospitalization for IRI was 7.9% and 90-days mortality was 10.3%. The risk (adjusted Hazard Ratio, 95% Confidence Interval) of IRI related 90-days mortality increased with age (50-59: 3.00, 0.65-13.94; 60-69: 4.16, 0.99-17.55; 70-79: 4.79, 1.16-19.76; 80+: 7.15, 1.74-29.46), heart failure (1.97, 1.31-2.98), renal disease (1.50, 1.05-2.14), and Charlson comorbidity index (1.14, 1.08-1.19). CONCLUSIONS: Older age, heart failure, renal disease, and Charlson comorbidity index were significant predictors of mortality following hospitalization for IRI in individuals with diabetes. These findings could help in improving the clinical management and performance of surveillance and health systems concerning IRI in Austria.

The interplay of sleep duration, working hours, and obesity in Korean male workers: The 2010-2015 Korea National Health and Nutrition Examination Survey.

The purpose of this study was to clarify the odds ratio for association between working hours and obesity in Korean male wage workers and investigate the role of sleep duration. This study is a cross-sectional one using large-scale national data from the Korea National Health and Nutrition Examination Survey collected between 2010 and 2015 to evaluate 2,592 male wage workers (between the ages of 19 and 60 years). Obesity was defined as 25kg/m2 or more and working hours per week were categorized into <40, 40-49, 50-59, and ≥60 hours. Multiple regression analysis was performed to examine the odds ratio for association between working hours and obesity, after controlling for age, education, income, marital status, smoking, drinking, physical activity, daily energy intake, sleep duration, hypertension, diabetes, dyslipidemia, work schedule, and job category. Next, to study the mediating effect of sleep duration on the association between working hours and obesity, an analysis was performed using the Baron and Kenny method and the Sobel test. Results showed that workers with 50 to 59 hours had 1.4 times higher odds (odds ratio [OR] = 1.4, confidence interval [CI]: 1.11-1.85) of obesity and workers with 60 hours or more had 1.4 times higher odds (OR = 1.4, CI: 1.06-1.90) of obesity than workers with less than 40 hours. Sleep was found to have a mediating effect on the association between working time and body mass index. Therefore, the results of this analysis suggest that practitioners should identify potential factors such as working time and sleeping time when preventing work-related obesity.

Lifestyle changes as a result of COVID-19 containment measures: Bodyweight and glycemic control in patients with diabetes in the Japanese declaration of a state of emergency.

To clarify the association between lifestyle changes as a result of coronavirus disease 2019 containment measures and changes in metabolic and glycemic status in patients with diabetes, a cross-sectional, single-center, observation study was carried out. A self-reported questionnaire was provided to ascertain the frequency of various lifestyle activities before and after the coronavirus disease 2019 containment measures in Japan. Among 463 patients, change in glycated hemoglobin was significantly associated with change in bodyweight. After stratification by age 65 years, binary logistic regression analysis showed that increased frequency of snack eating increased bodyweight (odds ratio 1.709, P = 0.007) and glycated hemoglobin (odds ratio 1.420, P = 0.025) in the younger group, whereas in the older patients, reduced walking activities resulted in weight gain (odds ratio 0.726, P = 0.010). In conclusion, changes in eating behavior and physical activity increased bodyweight and reduced glycemic control among diabetes patients, but by different processes depending on age under the coronavirus disease 2019 containment measures in Japan.

Long-Term Assessment of Rehabilitation Treatment of Sports through Artificial Intelligence Research.

BACKGROUND: Artificial intelligence (AI) technology has been incorporated into all walks of life, especially the integration of machine learning and health management has achieved very significant progress and results. It is very necessary to analyze personalized sports health management services and long-term assessment of health issues in the era of AI. METHODS: This paper explores AI + personalized sports management service system design ideas, system operation process, management stage design, taking common chronic diseases, and diabetes as examples. 150 patients were divided into an observation group and a control group, and the blood glucose, blood pressure, blood lipid, and knowledge awareness rate were compared. RESULTS: The blood glucose, blood pressure, and blood lipid levels of the observation group all reduced, and the awareness rate of diabetes knowledge increased, which proved that the AI research has great value in sports rehabilitation research coupled with long term health assessment and is worth further research. CONCLUSION: The AI research proposed in this paper is of far-reaching practical significance in helping the transformation and upgrading of the sports health management service industry, promoting the innovative development of sports health management service supply, and promoting national fitness and national health.

Impact of Diabetes Mellitus on Knee Osteoarthritis Pain and Physical and Mental Status: Data From the Osteoarthritis Initiative.

OBJECTIVE: Diabetes mellitus (DM) appears to increase osteoarthritic knee pain, which may be related to greater adiposity and more advanced disease status often observed in individuals with osteoarthritis (OA) and DM. We aimed to assess whether OA knee pain and health status are worse in individuals with OA and DM, independent of these potential confounders. METHODS: We included 202 OA participants with DM and 2,279 without DM from the Osteoarthritis Initiative. Knee pain was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and a numeric rating scale (NRS). Physical and mental status were assessed by the Medical Outcomes Study Short Form 12 (SF-12) questionnaire, physical component summary (PCS) score and mental component summary (MCS) score, and by the Center for Epidemiologic Studies Depression Scale (CES-D). Linear regression models assessed the influence of DM, adjusted for age, sex, body mass index (BMI), and radiographic severity. RESULTS: OA participants with DM reported worse knee pain and greater physical and mental issues compared with participants without DM. Individuals with DM had worse KOOS pain (ß = -4.72 [95% confidence interval (95% CI) -7.22, -2.23]) and worse NRS pain (ß = 0.42 [95% CI 0.04, 0.80]) independent of BMI, OA severity, age, and sex. The negative influence of DM was also apparent for SF-12 PCS (ß = -3.49 [95% CI -4.73, -2.25]), SF-12 MCS (ß = -1.42 [95% CI -2.57, -0.26]), and CES-D (ß = 1.08 [95% CI 0.08, 2.08]). CONCLUSION: Individuals with knee OA experience on average higher pain intensity and a worse physical and mental health status if they have DM. Linear regression models show that DM is a risk factor for higher pain, in addition to and independent of greater BMI and radiographic OA severity.

The cardiovascular determinants of physical function in patients with end-stage kidney disease on haemodialysis.

Patients with end-stage kidney disease (ESKD) are often sedentary and decreased functional capacity associates with mortality. The relationship between cardiovascular disease (CVD) and physical function has not been fully explored. Understanding the relationships between prognostically relevant measures of CVD and physical function may offer insight into how exercise interventions might target specific elements of CVD. 130 patients on haemodialysis (mean age 57 ± 15 years, 73% male, dialysis vintage 1.3 years (0.5, 3.4), recruited to the CYCLE-HD trial (ISRCTN11299707), underwent cardiovascular phenotyping with cardiac MRI (left ventricular (LV) structure and function, pulse wave velocity (PWV) and native T1 mapping) and cardiac biomarker assessment. Participants completed the incremental shuttle walk test (ISWT) and sit-to-stand 60 (STS60) as field-tests of physical function. Linear regression models identified CV determinants of physical function measures, adjusted for age, gender, BMI, diabetes, ethnicity and systolic blood pressure. Troponin I, PWV and global native T1 were univariate determinants of ISWT and STS60 performance. NT pro-BNP was a univariate determinant of ISWT performance. In multivariate models, NT pro-BNP and global native T1 were independent determinants of ISWT and STS60 performance. LV ejection fraction was an independent determinant of ISWT distance. However, age and diabetes had the strongest relationships with physical function. In conclusion, NT pro-BNP, global native T1 and LV ejection fraction were independent CV determinants of physical function. However, age and diabetes had the greatest independent influence. Targeting diabetic care may ameliorate deconditioning in these patients and a multimorbidity approach should be considered when developing exercise interventions.

Toe gaps and their assessment in footwear for people with diabetes: a narrative review.

BACKGROUND: Adequate footwear fit is critical in preventing diabetes-related foot ulcers. One important element is the toe gap, the difference between foot length and internal footwear length available to the foot. We summarised the literature on toe gaps in studies assessing footwear worn by people with diabetes, the methods used to measure both foot length and internal footwear length and identify ambiguities which may impact on toe gap assessment in clinical practice, and suggest pragmatic solutions. METHODS: The Google Scholar database was searched to April 2020 for peer-reviewed studies using keywords related to incorrectly fitting or ill-fitting and diabetes, foot and ulcer which returned 979 results. Included studies within this narrative review encompassed toe gap measurement to assess footwear worn by people with diabetes. RESULTS: A total of eight studies were included after full paper review. Toe gap ranges as used in assessments of footwear worn by people with diabetes vary, with a minimum of 1.0-1.6 cm and a maximum of 1.5-2.0 cm, as do methods of measuring internal footwear length. Only three published studies suggested possible measuring devices. CONCLUSIONS: Toe gap ranged as used when assessing footwear fit in people with diabetes vary and a gold standard device for internal footwear length measurement has yet to emerge. International guidelines provide welcome standardisation, but further research is needed to evaluate both the effect of toe gap ranges upon pressure, plantar stress response and ulceration and available measuring devices to facilitate development of toe gap measurement protocols that may further enhance consistency in practical assessments.

Cloridrato de Prasugrel para redução de eventos aterotrombóticos em pacientes diabéticos com síndrome coronariana aguda que realizaram angioplastia coronariana primária / Prasugrel hydrochloride to reduce atherothrombotic events in diabetic patients with acute coronary syndrome who underwent primary coronary angioplasty

INTRODUÇÃO: A síndrome coronariana aguda (SCA) é um termo abrangente para: infarto agudo do miocárdio (IAM) com supradesnivelamento do segmento ST, IAM sem supradesnivelamento do segmento ST e angina instável (1,2). A incidência é muito variável entre diferentes países e regiões do mundo (3­8). De acordo com a Organização Mundial da Saúde, doenças isquêmicas do coração foram responsáveis por 12% das mortes observadas em países de média e baixa renda, e aproximadamente 16% das mortes em países da alta renda em 2008 (9). Em particular, pacientes com diabetes mellitus (DM) possuem maior potencial pró-trombótico (3,4) e consequente maior potencial de beneficiarem-se de antiagregantes plaquetários (aspirina, clopidogrel) após uma angioplastia. O prasugrel é um anti-agregante plaquetário da mesma classe do clopidogrel, hoje incorporado ao SUS, e do ticagrelor, cuja incorporação foi rejeitada pela CONITEC. PERGUNTA: O prasugrel é eficaz, seguro e custo-efetivo em relação ao clopidogrel para a redução de eventos cardiovasculares em pacientes com síndrome coronariana aguda (SCA) e diabetes mellitus (DM) que realizaram angioplastia? EVIDÊNCIAS CIENTÍFICAS: Um único ensaio clínico randomizado (TRITON TIMI 38) avaliou prasugrel versus clopidogrel, 23% dos participantes eram diabéticos. Estudo patrocinado pelo demandante. Baixo risco de viés. A análise em pacientes diabéticos é baseada em uma análise de subgrupo. A qualidade da evidência é limitada pois não houve randomização para diabéticos e o estudo não foi controlado para o tipo e gravidade da doença. Ainda, a interação para diabetes não foi significativa (P = 0,09), ou seja, a análise deste subgrupo como um grupo independente não é adequada. A razão de chances, que no estudo pivotal era de 0,76 para redução de infarto foi recalculada para 0,60 no subgrupo de diabéticos. Analisando os resultados do subgrupo de pacientes diabéticos para o desfecho primário composto de morte cardiovascular, infarto e AVC, foram observados eventos em 17,0% no grupo clopidogrel e 12,2% no grupo prasugrel (HR=0,70; IC 0,58 - 0,85). Para morte cardiovascular, 4,2% no grupo clopidogrel e 3,4% no grupo prasugrel (HR=0,85; IC 0,58 - 1,24); IAM não fatal: 13,2% no grupo clopidogrel e 8,2% no grupo prasugrel (HR=0,60; IC 0,48 - 0,76); Trombose de stent: 3,6% no grupo clopidogrel e 2,0% no grupo prasugrel (HR=0,52; IC 0,33 - 0,84). O prasugrel apresentou maior risco de sangramentos não relacionada à cirurgia de revascularização miocárdica: 4,3% no grupo clopidogrel e 5,3% no grupo prasugrel (HR=1,30; IC 0,92 - 1,82). AVALIAÇÃO ECONÔMICA: A avaliação econômica do prasugrel apresentada pelo demandante baseou-se nos resultados do estudo pivotal e em um modelo de custo-efetividade e custo-utilidade utilizado previamente no NICE. Como resultados, prasugrel demonstrou-se ser mais efetivo e com maior custo em relação ao clopidogrel, apresentando uma razão de custo-utilidade incremental (RCEI) de R$ 9.325,00 mil/QALY. O modelo foi refeito pelo parecerista externo, obtendo um novo valor de RCEI de R$ 12.324,53/QALY e com 100% das simulações com valor igual ou inferior a R$ 15.591,13/QALY. RECOMENDAÇÃO PRELIMINAR DA CONITEC: A Conitec, em sua 89ª reunião ordinária, no dia 06 de agosto de 2020, recomendou a não incorporação no SUS de prasugrel para tratamento de pacientes diabéticos com síndrome coronariana aguda pós angioplastia. A recomendação levou em consideração que a população alvo foi mal definida, gerando incertezas no impacto orçamentário e na proposta de redução de preços. A operacionalização da proposta de redução de preços necessita de esclarecimentos. RECOMENDAÇÃO PRELIMINAR DA CONITEC: A Conitec, em sua 89ª reunião ordinária, no dia 06 de agosto de 2020, recomendou a não incorporação no SUS de prasugrel para tratamento de pacientes diabéticos com síndrome coronariana aguda pós angioplastia. A recomendação levou em consideração que a população alvo foi mal definida, gerando incertezas no impacto orçamentário e na proposta de redução de preços. A operacionalização da proposta de redução de preços necessita de esclarecimentos. RECOMENDAÇÃO FINAL DA CONITEC: Os membros da CONITEC presentes na 92ª reunião ordinária, no dia 05 de novembro de 2020, deliberaram por recomendar a não incorporação no SUS do cloridrato de prasugrel para pacientes diabéticos com síndrome coronariana aguda submetidos à angioplastia primária. Os membros presentes entenderam que o medicamento atenderia um subgrupo de pacientes específico e que ainda há incertezas quanto ao seu benefício e segurança. Foi assinado o Registro de Deliberação nº 573.

Implante biodegradável de dexametasona no tratamento do Edema Macular Diabético em pacientes não responsivos à terapia prévia com anti-VEGF / Biodegradable dexamethasone implant in the treatment of Diabetic Macular Edema in unresponsive patients previous anti-VEGF therapy

CONTEXTO: O edema macular diabético (EMD) é a principal alteração responsável por perda irreversível de acuidade visual em pacientes com diabetes mellitus (DM) que desenvolveram retinopatia diabética (RD). O EMD é caracterizado por inchaço na região central do olho resultado da ruptura da barreira sanguínea-retiniana e do acúmulo de líquido nas camadas intrarretinianas da mácula. A prevenção primária do EMD é o manejo ideal da doença, considerando a associação direta da prevalência do diabetes e da RD. As estratégias de tratamento consistem inicialmente no controle sistêmico da glicemia, da hemoglobina glicada (HbA1c), de lipídeos séricos, da função renal, estabilização da pressão sanguínea e controle do índice de massa corporal, associado à prática de exercícios físicos e alimentação adequada. O estágio da doença é determinante para a escolha do método de tratamento e o sucesso do tratamento é avaliado pela acuidade visual, pelo estadiamento da classificação da RD e pela análise dos exames complementares. Atualmente a terapia considerada padrão-ouro no tratamento do EMD consiste no uso do fator de crescimento endotelial anti-vascular (antiVEGF), mas em caso de insucesso terapêutico o emprego de corticoides em forma de implantes de liberação controlada tem sido utilizado. Pergunta: O uso do implante biodegradável de dexametasona (Ozurdex®) é eficaz, seguro e custo-efetivo para o tratamento de pacientes adultos com EMD, que falham à terapia com agente anti-VEGF? Evidências científicas: Dez publicações (uma revisão sistemática, dois ensaios clínicos e sete estudos observacionais) foram apresentados no relatório. De acordo com a metanálise, de qualidade metodológica moderada, há um ganho de 20 letras na BCVA (melhor acuidade visual corrigida) de pacientes tratados com o implante biodegradável de dexametasona, após um seguimento médio de avaliação de seis meses. A maioria dos estudos observacionais apontam melhora da BCVA em relação ao baseline do estudo. Os ensaios clínicos apresentaram um risco de viés moderado e um deles descreveu os achados anatômicos do estudo MEAD, avaliando as principais alterações morfológicas em relação ao baseline da ESCR, volume macular, área de espessamento da retina, vazamento macular, perda capilar macular e gravidade da retinopatia diabética. O implante de dexametasona atrasou o tempo de início da progressão do EMD em ± 12 meses, o que ao final do estudo, reduziu a espessura do subcampo central da retina (ESCR) em média 117,3 e 127,8 m nos grupos tratados com dexametasona versus 62,1 m nos olhos tratados com simulação (tratamentos p <0,001 vs, simulação). Entre os desfechos secundários avaliados estão: aumento da PIO, alterações da EFC, ESC e EMC, além de alterações do grau de retinopatia diabética. Os principais eventos adversos relatados em pacientes sob tratamento foram: descolamento de retina, inflamação da câmara anterior; dor ocular; queratite ou opacidade vítrea; e insurgência da catarata. AVALIAÇÃO ECONÔMICA: Foi conduzido um estudo de custo-efetividade e análises de sensibilidade univariada e probabilística. O tratamento com o implante biodegradável de dexametasona foi comparado com um procedimento simulado, ou não tratamento, num horizonte temporal de três anos. Para a indicação proposta, a incorporação da dexametasona resultaria em uma razão de custo-efetividade incremental (RCEI) estimada de R$ 54.568,99 por paciente e inclui custos de aquisição do medicamento, de administração, além de custos com visitas e de avaliação de eventos adversos. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: Dois cenários foram avaliados para estimar o impacto orçamentário (AIO) da incorporação da dexametasona. O cenário base foi representado por um impacto total de R$ 1,76 bilhões em uma estimativa epidemiológica e um total de R$ 159,61 milhões em uma estimativa por demanda aferida, enquanto o cenário por protocolo foi representado por uma economia acumulada total de R$ 39,11 milhões em uma estimativa epidemiológica e R$ 3,50 milhões em uma estimativa por demanda aferida, ambos os cenários em um horizonte temporal de 5 anos. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foi detectada uma tecnologia, a fluocinolona acetonida, também um corticoide cuja via de administração é a mesma do implante biodegradável de dexametasona. Os estudos sobre a tecnologia atualmente estão em fase 4. Além disso, foi detectado no horizonte o medicamento aganirsen, um oligonucleotídeo, inibidor do gene IRS1, que está em fase 2 de pesquisa clínica para a indicação. Considerações: A evidência disponível é baseada em estudos clínicos randomizados e estudos observacionais que comparam o período pré-dexametasona e pós-dexametasona. Comparada ao procedimento simulado a dexametasona demonstrou melhora dos desfechos observados (BCVA, EFC, PIO, ESC, EMC, morfologia da retina, alterações no grau de RD e segurança), no entanto, a qualidade das evidências foi considerada baixa. Limitações importantes também foram identificadas na ACE e na AIO, indicando provável superestimação dos valores no âmbito no SUS. DECISÃO PRELIMINAR da Conitec: Diante do exposto, a Conitec, em sua 89ª reunião ordinária, realizada no dia 05 de agosto de 2020, deliberou que a matéria fosse disponibilizada em consulta pública com recomendação preliminar desfavorável à incorporação no SUS do implante biodegradável de dexametasona para tratamento de pacientes com edema macular diabético não responsivos à terapia prévia com anti-VEGF. Considerou-se que as evidências apresentadas são insuficientes para os desfechos analisados, visto baixo nível de certeza apresentado. Além disso, do ponto de vista econômico, o uso de parâmetro inadequado no modelo ocorreu por parte do demandante, pois a dexametasona tem indicação apenas para pacientes não responsivos à terapia prévia com antiangiogênicos, dessa forma não cabe a comparação dos custos com o medicamento aflibercepte, considerando que não são tecnologias substitutas. A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: A Consulta Pública nº 50/2020 foi realizada entre os dias 15/09/2020 a 05/10/2020. Foram recebidas 400 contribuições, sendo 152 pelo formulário para contribuições técnico-científicas e 248 pelo formulário para contribuições sobre experiência ou opinião de pacientes, familiares, amigos ou cuidadores de pacientes, profissionais de saúde ou pessoas interessadas no tema. Dentre as 152 contribuições técnico-científicas, apenas 05 foram analisadas, pois 147 se tratavam de duplicatas, contribuições em branco, desprovidas de teor científico ou que tratavam de experiência ou opinião. As 05 contribuições consideradas para análise discordaram da recomendação preliminar da Conitec, tendo como justificativas: rápida resposta terapêutica da tecnologia, melhor responsividade em comparação à terapia com antiVEGF, bons resultados clínicos em casos de oclusões vasculares, olhos fácicos e uveítes inflamatórias, opção terapêutica em caso de contraindicação aos anti-VEGF ou dificuldade de seguimento. Dentre as 248 contribuições de experiência ou opinião recebidas, apenas 123 foram analisadas, pois 125 se tratavam de duplicatas ou contribuições em branco. Dentre as 123 analisadas, 105 discordaram da recomendação preliminar da Conitec, tendo como argumentações: o implante de dexametasona se trata de única terapia corticoide pós falha terapêutica aos anti-VEGF, pois o aumento de citocinas, em alguns casos, só são controladas pelo corticoide; o implante ser menos oneroso que o custo social quando há perda irreversível de visão dos pacientes; e restrição de uso, no SUS, de um medicamento já disponível no rol de procedimentos da Agência Nacional de Saúde Suplementar (ANS). O demandante e fabricante da tecnologia enviou nova proposta de preço para incorporação com 25% de desconto, junto à nova análise de custo-efetividade e impacto orçamentário, que foram apresentados aos membros do plenário. Além desta, outras contribuições analisadas foram importantes para a complementação do relatório, especialmente por trazer as expectativas de adesão ao procedimento, por profissionais e pacientes. RECOMENDAÇÃO FINAL: Os membros do plenário presentes na 92ª reunião ordinária da Conitec, no dia 04 de novembro de 2020, deliberaram, por unanimidade, recomendar a não incorporação, no SUS, do implante biodegradável de dexametasona para tratamento de pacientes com edema macular diabético não responsivos à terapia prévia com antiVEGF. Foi considerado que ainda há alguns aspectos não esclarecidos sobre a prática clínica no cuidado do EMD, como o limiar de ineficácia ou insucesso terapêutico com anti-VEGF e que faltam evidências científicas que indiquem se a tecnologia avaliada seria substitutiva para os anti-VEGF ou se deveria ser criada uma segunda linha para o cuidado do EMD. Reiterou-se que as evidências avaliadas no relatório técnico não foram consideradas robustas o suficiente para a tomada de decisão em favor da incorporação do implante biodegradavel de dexametasona em casos de ineficácia terapêutica com anti-VEGF, que foi a proposta apresentada pelo demandante. Ademais, não foram adicionadas na CP referências que alterassem a análise das evidências apresentadas no relatório preliminar. Foi assinado o Registro de Deliberação nº 570/2020. DECISÃO: Não incorporar o implante biodegradável de dexametasona no tratamento do edema macular diabético em pacientes não responsivos à terapia prévia com anti-VEGF, no âmbito do Sistema Único de Saúde - SUS, conforme Portaria nº 58, publicada no Diário Oficial da União nº 228, seção 1, página 716, em 1º de dezembro de 2020.

Non-communicable diseases and inequalities increase risk of death among COVID-19 patients in Mexico.

BACKGROUND: The SARS-CoV-2 pandemic compounds Mexico's pre-existing challenges: very high levels of both non-communicable diseases (NCD) and social inequity. METHODS AND FINDINGS: Using data from national reporting of SARS-CoV-2 tested individuals, we estimated odds of hospitalization, intubation, and death based on pre-existing non-communicable diseases and socioeconomic indicators. We found that obesity, diabetes, and hypertension are positively associated with the three outcomes in a synergistic manner. The municipal poverty level is also positively associated with hospitalization and death. CONCLUSIONS: Mexico's response to COVID-19 is complicated by a synergistic double challenge: raging NCDs and extreme social inequity. The response to the current pandemic must take both into account both to be effective and to ensure that the burden of COVID-19 not falls disproportionately on those who are already disadvantaged.

A Cost-Effectiveness Analysis Comparing Single-use and Traditional Negative Pressure Wound Therapy to Treat Chronic Venous and Diabetic Foot Ulcers.

Lower extremity ulcers such as venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) have a major clinical and economic impact on patients and providers. PURPOSE: The purpose of this economic evaluation was to determine the cost-effectiveness of single-use negative pressure wound therapy (sNPWT) compared with traditional NPWT (tNPWT) for the treatment of VLUs and DFUs in the United States. METHODS: A Markov decision-analytic model was used to compare the incremental cost and ulcer weeks avoided for a time horizon of 12 and 26 weeks using lower extremity ulcer closure rates from a published randomized controlled trial (N = 161) that compared sNPWT with tNPWT. Treatment costs were extracted from a retrospective cost-minimization study of sNPWT and tNPWT from the payer perspective using US national 2016 Medicare claims data inflated to 2018 costs and multiplied by 7 to estimate the weekly costs of treatment for sNPWT and tNPWT. Two (2) arms of the model, tNPWT and sNPWT, were calculated separately for a combination of both VLU and DFU ulcer types. In this model, a hypothetical cohort of patients began in the open ulcer health state, and at the end of each weekly cycle a proportion of the cohort moved into the closed ulcer health state according to a constant transition probability. The costs over the defined timescale were summed to give a total cost of treatment for each arm of the model, and then the difference between the arms was calculated. Effectiveness was calculated by noting the incidence of healing at 12 and 26 weeks and the total number of open ulcer weeks; the incremental effectiveness was calculated as sNPWT effectiveness minus tNPWT effectiveness. Data were extracted to Excel spreadsheets and subjected to one-way sensitivity, scenario (where patients with unhealed ulcers were changed to standard care at 4 or 12 weeks), probabilistic, and threshold analyses. RESULTS: sNPWT was found to provide an expected cost saving of $7756 per patient and an expected reduction of 1.67 open ulcer weeks per patient over 12 weeks and a cost reduction of $15 749 and 5.31 open ulcer weeks over 26 weeks. Probabilistic analysis at 26 weeks showed 99.8% of the simulations resulted in sNPWT dominating tNPWT. Scenario analyses showed that sNPWT remained dominant over tNPWT (cost reductions over 26 weeks of $2536 and $7976 per patient, respectively). CONCLUSION: Using sNPWT for VLUs and DFUs is likely to be more cost-effective than tNPWT from the US payer perspective and may provide an opportunity for policymakers to reduce the economic burden of lower extremity ulcers.

Longitudinal assessment of the health-related quality of life among older people with diabetes: results of a nationwide study in New Zealand.

BACKGROUND: The current work examined experiences of Health-Related Quality of Life (HRQOL) among older adults with a diagnosis of Diabetes Mellitus (DM) over time compared to those without a diagnoses DM. METHODS: The sample was drawn from six biennial waves of the New Zealand Health, Work and Retirement survey, a prospective population-based cohort study of older adults 55-70 years at baseline. Data on sociodemographic factors, health behaviours, chronic disease diagnoses and physical and mental HRQOL (SF-12v2) were obtained using six biennial surveys administered 2006-2016. Generalised Estimating Equation models, adjusted for time-constant and -varying factors, were employed to compare HRQOL and its determinants over time for older adults with and without a diagnosis of DM. RESULTS: DM was negatively associated with physical HRQOL [ß (95% CI) - 7.43 (- 8.41, - 6.44)] with older adults affected by DM reporting scores 7.4 points lower than those without DM. Similarly, the mean Mental HRQOL score was lower among those affected by DM [ß = - 4.97 (- 5.93, - 4.01)] however, scores increased over time for both groups (p < 0.001). Greater age, more chronic conditions, sight and sleep problems, obesity, lower annual income, and fewer years of education were predictors of poorer HRQOL among older adults. CONCLUSIONS: Older adults affected by diabetes experienced poorer physical and mental HRQOL compared to those not affected when controlling for a range of sociodemographic and health related indices. A management aim must be to minimise the gap between two groups, particularly as people age.

Correlation between fractional flow reserve and instantaneous wave-free ratio with morphometric assessment by optical coherence tomography in diabetic patients.

Currently there is lack of data regarding the use of optical coherence tomography (OCT) to depict the hemodynamic relevance of coronary stenoses in diabetic patients. We sought to assess the diagnostic accuracy of OCT-derived morphologic assessment in identifying hemodynamically significant coronary lesions as determined by both, the resting instantaneous wave-free ratio (iFR) and the hyperemic fractional flow reserve (FFR) in diabetic patients. Diabetic patients presenting with at least one intermediate coronary lesion were prospectively and consecutively enrolled. All lesions were systematically assessed by iFR, FFR and OCT. A total of 41 intermediate lesions were analysed. Mean iFR and FFR values were 0.90 ± 0.04 and 0.81 ± 0.06, respectively (intra-class correlation coefficient 0.49; 95% CI 0.22-0.79). A moderate correlation between iFR and OCT derived minimal lumen diameter (MLD, r = 0.49) and minimal lumen area (MLA, r = 0.50) was found. Conversely, there was a poor correlation between FFR and OCT-derived MLD (r = 0.34) and MLA (r = 0.32). The diagnostic efficiency of MLA and MLD to identify iFR significant stenoses showed an AUC of 0.82 (95% CI 0.69-0.95) for MLD and 0.83 (95% CI 0.71-0.96) for MLA. A worse diagnostic efficiency was found when FFR was used as the reference with an AUC of 0.71 (95% CI 0.54-0.87) for MLD and 0.70 (95% CI 0.53-0.87). OCT-derived MLA and MLD were the strongest independent anatomic predictors of abnormal iFR and FFR values. In diabetic patients, OCT-derived MLA and MLD showed a moderate diagnostic efficiency in identifying functionally significant coronary stenoses by FFR or iFR. In diabetics, anatomic OCT measurements better predicted resting than FFR-determined physiologically significant lesions.

Assessment of Lactate Dehydrogenase Levels Among Diabetic Patients Treated in the Outpatient Clinics at King Hussein Medical Center, Royal Medical Services, Jordan.

INTRODUCTION: Diabetes is a chronic disease and usually is associated with inflammatory conditions. Although assessment of inflammatory markers such lactate dehydrogenase (LDH) is not likely to be conducted in routine practice, it can help in monitoring disease progress. AIM: The main objectives of the present study are to assess the levels of LDH among diabetic patients treated in the outpatient clinics at King Hussein Medical Center, and to investigate the relationships between the levels of LDH and other variables such as age, gender, BMI, and glucose levels. METHODS: A retrospective study was conducted to collect data from files of diabetic patients. A total of 62 files were selected. Files of diabetic patients were included if complete information including LDH are included. An excel sheet was used to enter the raw data for all patients. The data were analyzed using SPSS version 20. Data were presented as means, standard deviations, frequencies and percentages. The relationships between variables were computed using T test, and Chi-square. The significance will be considered at p ≤ 0.05. RESULTS: The mean age was 75±12 years. About 53% of participants were males. The mean of BMI was 31.47±20.90 kg/m2. The mean glucose level was 239±85 mg/dl. The mean level of LDH was 328.34±78 U/L. There was a significant association between the level of LDH and study variables. Gender had no significant impacts on the levels of LH and other study variables. CONCLUSION: Determination of the level of LDH helps in assessment of progression of diabetes and it is recommended to be performed clinically in routine practice.

Using the ICF framework to evaluate the effects of environmental factors on physical disability among people with diabetes mellitus.

Objective: This study aimed to analyze the influence of environmental factors on the ICF activity-participation outcome, controlling for body function and personal factor dimensions of 75 diabetes patients. Method: Outcome measures included questionnaires on musculoskeletal pain (Nordic Questionnaire), physical and environment domains of World Health Organization Quality of Life version BRIEF (WHOQOL-brief) and clinical and personal data. Multiple linear regression with hierarchical entry of variables was used. Results: An assessment of WHOQOL-brief revealed a score of 66.6 (SD = 17.3) to physical domain and 58.8 (DP = 12.1) to environment domain. The factors associated with physical domain were lower limb pain, number of comorbidities, and environment barriers. The highest environmental barriers were financial constraints, availability of health services, deficiency of self-management, and inadequate family and social support. The final model explained 44.0% (F[12.02], p < 0.001) of variability of the physical domain. Conclusions: We confirmed the functional consequences of diabetes mellitus to be complex and multifactorial. An approach that considers the interaction between individual and environmental attributes is necessary due to the disabling nature of this health condition.

Diabetes mellitus y covid-19: epidemiología, fisiopatología, manejo ambulatorio e intrahospitalario: revisión / Diabetes mellitus and covid-19: epidemiology, pathophysiology, outpatient and inpatient management: review

La diabetes mellitus ha sido asociado a una mayor probabilidad de enfermedad más grave por Covid-19. Los estudios epidemiológicos evidencian que los pacientes diabéticos tienen un riesgo mayor de un cuadro grave que requiera UCI, ventilación mecánica y probabilidad de morir. Un buen control metabólico parece fundamental para disminuir este riesgo. En el caso del manejo ambulatorio es importante asegurar la continuidad de los tratamientos crónicos, medir los niveles de glicemia capilar y minimizar la posibilidad de infección. En caso de infección por SARS-Cov2 el paciente diabético deberá hacer los ajustes necesarios en su tratamiento tanto para lograr un control glicémico adecuado como para disminuir los riesgos de algunos fármacos antidiabéticos. El uso de telemedicina constituye una excelente herramienta para facilitar el logro de los objetivos terapéuticos. En caso de requerir hospitalización, se ha evidenciado que los pacientes diabéticos tienen altos requerimientos de insulina y rápida tendencia a producir cetosis. Considerando la situación actual de pandemia las metas intrahospitalarias pueden ser más laxas y seguras, en especial en pacientes no críticos. En caso de pacientes críticos idealmente se debe mantener las metas glicémicas entre 140-180 mg/dL.

Diabetes mellitus has been associated with a higher probability of severe disease due to Covid-19. Epidemiological studies show that diabetic patients have an increased risk of a serious condition requiring ICU, mechanical ventilation and of course the probability of dying. Good metabolic control seems essential to reduce this risk. In the case of outpatient management, it is very important to ensure the continuity of chronic treatments, measure capillary blood glucose levels and minimize the possibility of infection. In case of SARS-Cov2 infection, the diabetic patient should make the necessary adjustments in their treatment, both to achieve adequate glycemic control and to reduce the risks of some antidiabetic drugs. Telemedicine is an excellent tool to facilitate the achievement to therapeutic goals. In case of requiring hospitalization, it has been shown that diabetic patients have high insulin requirements and rapid tendency to produce ketosis. Considering the current situation of a pandemic, intrahospital goals may be laxer and safer, especially in non-critically ill patients. In the case of critically ill patients, the glycemic goals should ideally be maintained between 140-180 mg/dL.